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Quality Assurance Control

Location:
Philadelphia, Pennsylvania, United States
Salary:
Qpen
Posted:
January 19, 2017

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Robert W. Burns

acydfz@r.postjobfree.com

(215) ***-****

**** ***** **

Philadelphia, PA 19114

Objective

To obtain a position in order to utilize my experience and theoretical knowledge to improve quality, productivity, and results.

Work History

Quality Control Warehouse Distribution, Ancillare Global Clinical Strategies, Jan 2014 to Present

Perform in-line inspection of goods being assembled for shipments to global clinical trial sites or partner/vendor locations.

Perform physical and visual incoming inspections of goods received into the warehouse.

Generate inventory status labels, participate in physical inventory, perform cycle counts, and maintain stock locations for material expiration dates.

Review and inspect good in the quarantine and reject cages to ensure proper labeling and to verify and monitor expiry dates of goods.

Quality Assurance Inspector, Quality Assurance, Veridex, LLC (a Johnson & Johnson Company), Jan. 2013 to May 2013 (Contract Position)

Perform inspection including, but not limited to, raw material control, components inspection, product evaluation, validation analysis, and special projects as assigned.

Inspect the contents of sealed test tubes for visible debris fibers, glass, and particulates using backlighting.

Segregate acceptable product from rejected product in a manner that allows reconciliation of all product test tubes.

Quality Assurance Lead Inspector, Quality Assurance, Lannett Company Inc., Jan. 2009 to March 2011

Lead Quality Role and Team Leader

Supervisory and Training of Quality Staff and New Hires

SOP Writing and Review

Auditing, Daily Quality Reviewing of Equipment and Processes, and Safety Training

Preformed Inspections During, Throughout, and After the Manufacturing Process

Raw Material Sampling and Preparation, Including but not Limited to both Controlled and Uncontrolled Active Pharmaceutical Ingredients (API) and Various Pharmaceutical Excipients

Active Drug Blending, Compression, and Encapsulation

Thorough and Detailed Pre-production Room Inspections, Assured Proper and Extensive Cleanings of the Rooms Before Productions, and Prepared the Componentry Required for the Production of New Batches

Quality Control Active Drug Swabbing for Cleaning, Release, and Validation

Preformed Inspections for Warehouse/Packaging Department.

Measured and Released Incoming Components such as Bottles, Caps, Folding Cartons, and Shippers Required Specifically for Each Individual Product

Process Auditing of Pharmaceutical Packaging Lines

Experienced and Authorized to Handle, Weigh, and Transport Controlled Substances

Batch Record Preparation, Confirmation, and Auditing

Managed SAP Operation System for Real-Time Transport of Materials and also for Procurement Purposes

Well Trained and Experienced with Proper Gowning Techniques and Use of Personal Protective Equipment, Various Types of Respirators, and Powered Air-Purifying Respirators (PAPR)

Extensive Knowledge of the Pharmacy, Proper Laboratory Technique, Handling of Controlled Substances CI through CV, and Raw Material Sampling

Quality Assurance Lead Inspector, Quality Assurance, Impax Laboratories Inc., Mar. 1999 to Aug. 2008

Served as Lead Role QA Inspector with Escalated Issues on Packaging Lines and Warehouse Distribution

Overseeing of Bulk Holding Studies and Multiple Cleaning Validations

Process Auditing of Pharmaceutical Packaging Lines and Providing Support for Packaging Personnel

Trained Quality Assurance, Inspection and Packaging Staff

Performed Various Quality Inspections on a Daily Basis

Measured, Inspected, and Released Incoming Components such as Bottles, Caps, Folding Cartons, and Shippers

Handled, Weighed, and Transported Controlled Substances

Supervised Clinical Trial Runs and Operations in order to Ensure the Product was of the Highest Quality

Personally Prevented a Number of Potential Recalls and Deviations Regarding the Quality of Prodct

AQL Sampling of Bulk Materials

Label Verification, Review, Correction, Printing and Applying of Finished Labels to Packaged Product

Assisted in Preparing Corrective and Preventive Actions (CAPA) Following Uncontrolled Deviations

Prepared, Corrected, and Reviewed Live Batch Records

Improved Current Processes and Prepared and Revised Multiple SOP’s

Senior Inspector, Quality Assurance, J.W.S. Delavau/Accucorp Pharmaceutical Packaging Inc., Oct. 1993 to Dec. 1998

Supervisor to 3-4 Quality Assurance and 6-8 Warehouse Personnel

Performing Various Quality Assurance and Inspecting Tasks

Incoming Components such as Bottles, Caps, Folding Cartons, Shippers, and Raw Material Sampling

In-process Inspection of Tablet Compression, Friability

Destruction of Rejected and In-process Waste Materials

Holding of Non-conforming Product Materials

Achieving Master Packaging Specifications

Inspector, Quality Assurance, Paper Manufacture Co., May 1983 to June 1993

Quality Control Inspector of the Medical Packaging Department

Blueprinting of Product Used for Inspection of Medical Patches

In-process Inspection of Eight (8) Medical Packaging Machines

Medical Packaging Machine Operator

Education

South Philadelphia High School Graduate

2101 South Broad Street

Philadelphia, PA 19148

Training

SOP, cGMP, SPC, ISO9000, Lean Manufacturing, and SAP Systems

Computer Proficiency Including but not limited to Microsoft Word, Outlook, Excel, and PowerPoint



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